Schwann Cell Therapy for Peripheral Nerve Injury

Overseen By George Jimsheleishvili, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: W. Dalton Dietrich

Disqualifiers: Pregnancy, HIV, Hepatitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-transplantation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with severe peripheral nerve injuries affecting the arms or legs. It examines whether adding Schwann cells, special cells from the patient's own nervous system, to the nerve repair process can enhance recovery. The primary goal is to assess the safety of using these cells to aid nerve healing. Suitable candidates have experienced a major nerve injury with a large gap (5-10 cm) between nerve endings within the past year. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that autologous human Schwann cells are likely to be safe for humans?

Research has shown that using a person's own Schwann cells (ahSCs) has been tested for safety in treating nerve injuries. In one study, doctors transplanted these cells into six patients with nerve injuries to assess safety. The study found no serious side effects, indicating that the treatment was well-tolerated. Additionally, a review of animal studies showed promising results for using Schwann cells in nerve repair, without major safety concerns.

As this treatment remains in the early testing stages, the primary focus is on evaluating its safety. This means more information is needed to fully understand its safety profile. However, the early findings are encouraging and suggest that the treatment is likely safe so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peripheral nerve injury?

Unlike the standard treatments for peripheral nerve injury, which often involve surgery or physical therapy to repair or manage symptoms, Schwann Cell Therapy uses autologous human Schwann cells. These cells are harvested from the patient's own sural nerve, which is a unique approach. Researchers are excited because these cells have the potential to promote nerve regeneration naturally and could lead to more effective and quicker recovery. This personalized cell therapy approach offers a promising alternative to traditional methods by directly enhancing the body's ability to heal itself.

What evidence suggests that autologous human Schwann cells might be an effective treatment for peripheral nerve injury?

Research has shown that using a person's own Schwann cells (ahSCs) can help treat serious nerve injuries. These cells support nerve repair by promoting the growth of nerve fibers and restoring the protective layer around nerves. In animal studies, Schwann cell therapy demonstrated clear potential to improve nerve function. Early results in humans also suggest that this treatment effectively aids patients with nerve injuries. Overall, evidence indicates that ahSCs may enhance nerve repair and improve recovery after injury. ^{1 3 6 7 8}

Who Is on the Research Team?

Allan Levi, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have had a severe peripheral nerve injury with a gap of 5-10 cm between healthy nerve endings within the last year. It's not suitable for those unable to undergo an MRI, with conditions affecting sural nerve harvest, gaps over 10 cm, local cancer history, pregnant women, or those with certain diseases or substance abuse.

Inclusion Criteria

I have a nerve injury with a gap of 5 to 10 cm between ends.

I have had a severe nerve injury in my arm or leg within the last year.

I have had a severe nerve injury in my arm or leg within the last year.

Exclusion Criteria

I do not have any health conditions that could affect my safety or participation in the study.

I have had cancer or radiation in the area where I now have nerve damage.

You have a severe injury to the nerves in your arms or legs that is longer than 10 centimeters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous human Schwann cells harvested from their own sural nerve for nerve autograft repair

Immediate post-transplantation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, sensory recovery, and nerve-graft continuity

5 years

Long-term safety monitoring

Participants are monitored for adverse events, tumorigenesis, and unexpected changes in nerve structure

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Human Schwann Cells

Trial Overview The study tests whether using one's own Schwann cells (ahSC) to repair damaged nerves can improve healing and function. Participants will receive ahSCs during surgery where their own nerves are used as grafts in areas like the sciatic nerve or brachial plexus.

How Is the Trial Designed?

Group I: Autologous human Schwann cells Experimental Treatment 1 Intervention

All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Who Is Running the Clinical Trial?

W. Dalton Dietrich

Lead Sponsor

Trials

7

Recruited

60+

The Miami Project to Cure Paralysis

Collaborator

Trials

6

Recruited

40+

Published Research Related to This Trial

A 1-year follow-up study of four patients with chronic spinal cord injury treated with autologous Schwann cell transplantation showed no adverse effects, indicating that the procedure is generally safe.

Only one patient experienced motor and sensory improvement after the transplantation, suggesting that while Schwann cell transplantation is safe, its efficacy in promoting recovery from spinal cord injury remains uncertain and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic thoracic spinal cord injury patients with autologous Schwann cell transplantation: an interim report on safety considerations and possible outcomes. Saberi, H., Moshayedi, P., Aghayan, HR., et al.[2008]

The study developed a rapid protocol for creating pure cultures of genetically modified adult human Schwann cells, which are crucial for repairing peripheral nerves.

Using an optimized electroporation method, nearly half (48.4%) of the Schwann cells were successfully transfected to produce proteins that promote nerve regeneration, indicating a promising approach for enhancing nerve repair strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous adult human Schwann cells genetically modified to provide alternative cellular transplants in peripheral nerve regeneration. Haastert, K., Mauritz, C., Matthies, C., et al.[2006]

Using human autologous serum instead of fetal bovine serum for cultivating human schwann cells significantly enhances the safety of clinical cell transplantation procedures, as demonstrated in a study involving 10 sural nerves from brain death donors.

The study achieved a high cell purity of 97% to 99% (mean 98.11%) without the use of growth factors, indicating that clinical-grade schwann cell cultivation is feasible and can meet safety standards for future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical grade cultivation of human Schwann cell, by the using of human autologous serum instead of fetal bovine serum and without growth factors. Aghayan, HR., Arjmand, B., Norouzi-Javidan, A., et al.[2012]

Autologous adult human Schwann cells (SCs) show promise for spinal cord injury repair, with research over the past 40 years establishing their potential for clinical trials.

Studies in rat models have demonstrated that transplanted SCs can promote spinal cord repair, and preparations are underway for FDA-approved clinical trials to test this therapy in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From transplanting Schwann cells in experimental rat spinal cord injury to their transplantation into human injured spinal cord in clinical trials. Bunge, MB., Monje, PV., Khan, A., et al.[2018]

A Phase I clinical trial involving six paraplegic participants demonstrated that transplanting autologous human Schwann cells into the spinal cord injury site is safe, with no surgical or neurological complications observed one year post-transplantation.

The study confirmed the feasibility of harvesting Schwann cells from a peripheral nerve and transplanting them within 4-7 weeks of injury, indicating a potential therapeutic approach for enhancing recovery after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. Anderson, KD., Guest, JD., Dietrich, WD., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03999424

Autologous Human Schwann Cells in Peripheral Nerve ... The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0024320524007197

Schwann cell autotransplantation for the treatment of ... Transplantation using autologous Schwann cells has shown good efficacy for patients with peripheral nerve injury.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9372346/

Systematic review of the therapeutic use of Schwann cells in ... Based on contemporary literature, SCs have demonstrated clear potential in the repair of peripheral nerve injury in animal studies.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224005298

Advances of Schwann cells in peripheral nerve regeneration In this review, we summarize the role of Schwann cells and recent advances in Schwann cell therapy in peripheral nerve regeneration.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39393574/

Schwann cell autotransplantation for the treatment of ... ... autologous Schwann cells has shown good efficacy for patients with peripheral nerve injury. In recent years, Schwann cell autologous ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28225648/

Safety of Autologous Human Schwann Cell ... A Phase I clinical trial was conducted to evaluate the safety of autologous human SC transplantation into the injury epicenter of six subjects with subacute ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/partner/gnf/trial/360596

Safety and Efficacy of Autologous Human Schwann Cell ... The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with ...

8. frontiersin.org frontiersin.org/journals/cellular-neuroscience/articles/10.3389/fncel.2022.929593/full

Systematic review of the therapeutic use of Schwann cells ... Based on contemporary literature, SCs have demonstrated clear potential in the repair of peripheral nerve injury in animal studies.